Is CE marking mandatory in Georgia?

While not strictly mandatory for all classes, having a CE mark greatly simplifies the registration process through the "recognition regime," speeding up approval.

Is there VAT on medical devices?

Many medical devices and pharmaceuticals are exempt from import VAT, but the HS code must match the exemption list in the Tax Code exactly.

Do instructions need to be in Georgian?

Yes, selling medical products without instructions and labeling in the Georgian language is prohibited and punishable by fine.

Who can be the registration holder?

Either a resident company or a foreign manufacturer can initiate registration, but a local authorized representative is often required for communication.

Medical Device Regulations Georgia — Compliance

Medical device regulations in Georgia have significantly tightened in recent years, aligning closely with EU standards. The import and sale of medical products (equipment, consumables, diagnostic tools) require strict compliance with regulatory requirements, including state registration, labeling, and quality control. Improperly documented imports often lead to cargo being held at customs, which is critical for perishable or urgently needed medical supplies. Additionally, certain categories of medical goods enjoy tax exemptions (e.g., VAT exemption), the utilization of which requires knowledge of specific codes and documentation. Consequently, this field demands a synthesis of pharmaceutical law and customs/tax regulations.

What Do Medical Device Regulation Services Cover?

Specialists on Legal.ge assist importers and distributors in gaining smooth market access for their products. The services include:

State Registration: Registering medical devices with the Regulation Agency of the Ministry of Health, preparing dossiers, and submission.
Customs Classification: Correctly classifying goods (assigning HS codes) to determine if they qualify for VAT exemption or require special permits.
Labeling and Marking Consultation: Preparing Georgian labels and instructions in compliance with legislation, which is mandatory for sale.
Permit Acquisition: Obtaining import permits for equipment subject to special control (e.g., containing radioactive sources).
Compliance Audit: Reviewing existing processes to determine the company's readiness for inspections conducted by the regulator.

Common Situations and Scenarios

In practice, it is common for an importer to bring in expensive equipment (e.g., ultrasound machines), only to find at customs that it has not undergone registration or its CE certificate is not recognized. This leads to cargo detention in warehouses and accumulating daily fines. A second scenario involves VAT payment: a company imports a dental chair and pays 18% VAT, whereas by specifying the correct code and confirming medical purpose, they could have benefited from an exemption. Labeling is also critical—if a product on the market lacks instructions in Georgian, the company is fined, and the product is subject to recall.

Medical Device Regulations